XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study (XP China SAS)

Evaluate the Continued Safety and Effectiveness of the XIENCE PRIME EECSS in a Cohort of Real-world Patients Receiving the XIENCE PRIME EECSS During Commercial Use.

Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.

This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China.

This study has no primary outcome measure. All observations are of equal weight.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease; Cardiovascular Disease; Coronary Heart Disease; Stent Thrombosis; Coronary Restenosis; Vascular Disease; Angioplasty
• Intervention / Treatment: Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

• Study Type: Observational
• Enrollment (Actual): 2002

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Clara, California, United States, 95054
      • Abbott Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in realworld settings in China.

Description

Inclusion Criteria:

• The patient must be at least 18 years of age at the time of signing the informed consent.
• The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF).
• Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.

Exclusion Criteria:

• No other exclusion criteria are specified for this study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS); Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)	Device: XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS); Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 through 1885 Days
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints	All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints	All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 through 1885 Days
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.; Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.; Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 through 1885 Days
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)	All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)	All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 through 1885 Days
Number of Participants With Target Lesion Failure (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With Target Lesion Failure (TLF)	Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 through 1885 Days
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)	Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 through 1885 Days
Number of All Death (Cardiac, Vascular, and Non-cardiovascular)	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)
Number of All Death (Cardiac, Vascular, and Non-cardiovascular)	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight. - Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 through 1885 Days
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	Myocardial Infarction (MI); Q wave MI Development of new, pathological Q wave on the ECG; Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)	Myocardial Infarction (MI); Q wave MI Development of new, pathological Q wave on the ECG; Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 through 1885 Days
Number of Participants With All Target Vessel Revascularization (TVR)	Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With All Target Vessel Revascularization (TVR)	Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 through 1885 Days
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])	This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention	≤ 7 days after index procedure (Hospitalization)
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])	This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention	0 through 1885 Days
Number of Participants With Acute Stent Thrombosis	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"	0 to 1 day
Number of Participants With Sub-acute Stent Thrombosis	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"	> 1 day to 30 days
Number of Participants With Early Stent Thrombosis	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"	0 - 30 days
Number of Participants With Late Stent Thrombosis	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"	31 to 365 days
Number of Participants With Very Late Stent Thrombosis	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"	> 365 days
Number of Participants With Overall Stent Thrombosis	This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"	0 to 1885 days
Number of Participants With Target Vessel ARC MI	This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With Target Vessel ARC MI	This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.	0 to 1885 days
Number of Participants With All TVR (TLR and TVR, Non-target Lesion)	This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)	≤ 7 days after index procedure (Hospitalization)
Number of Participants With All TVR (TLR and TVR, Non-target Lesion)	This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)	0 to 1885 days
Number of Participants With All TLR	This study has no primary or secondary endpoints, all endpoints are of equal weight.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With All TLR	This study has no primary or secondary endpoints, all endpoints are of equal weight.	0 to 1885 days
Number of Participants With ID-TLR	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With ID-TLR	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.	0 to 1885 days
Number of Participants With ID-TVR, Non-target Lesion	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With ID-TVR, Non-target Lesion	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.	0 to 1885 days
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.	≤ 7 days after index procedure (Hospitalization)
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)	This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.	0 to 1885 days

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Junbo Ge, MB, MSc, MD, Fudan University; Principal Investigator: Fang Chen, MD, Anzhen hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): October 9, 2019

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Actual): May 26, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Cardiovascular Disease; Myocardial Infarction; Stent Thrombosis; Coronary Heart Disease; XIENCE V EECSS; XIENCE PRIME EECSS; XIENCE PRIME; SPIRIT PRIME; XIENCE PRIME SV (Small Vessel); XIENCE PRIME LL (Long Lesion)
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Coronary Stenosis; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Vascular Diseases; Thrombosis; Coronary Restenosis; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 12-396